Conventional minimally invasive medical procedures, such as laparoscopic and interventional procedures, often require the surgeon to deliver a securing element, such as a clip, into the body. Many medical procedures require these securing elements to fix an implant, such as a stent-graft or mesh material, in a specific location in the body. For example, securing a stent-graft in place using a plurality of clips helps to prevent leaks in the stent-graft, which can compromise the efficacy of the surgical repair.
Frequently, due to the imprecision of these conventional securing element delivery techniques, the elements tend to migrate, resulting in leakage in the stents. As such, it is a goal to improve the precision with which the securing elements are placed and fixed.
One conventional device and method for delivering and fixing an implant in the body is to use a cannula loaded with the implant to the desired location. The cannula or housing is then pulled back and the implant is launched or sprung into placed, in a “jack in the box” type manner. As such, the implant is launched into place, with the surgeon having minimal control as to the placement of implant. According to another approach, the implant includes one or more hooks or other securing elements attached thereto, which upon launching, embed into the target region. Once again, because the deployment of the implant is imprecise, if the implant is improperly placed, the coupling effect of the hooks makes it difficult to remove and re-position. Still other conventional suturing techniques require two hands to grip and pull sutures in place.
Delivery and placement of securing elements is a critical part of many medical procedures, including but not limited to laparoscopic produces (e.g., hernia repair, gynecologic surgery, etc.) and other interventional procedures (e.g., minimally invasive heart surgery, etc.)
One exemplary application which involves the delivery and placement of securing elements in the body is the treatment of abdominal aortic aneurysms. The aorta is a major artery in the human body that extends from the heart down through the abdomen and branches out into other arteries that supply blood and oxygen to all organs. Due to its size and function, the aorta is commonly considered one of the most important arteries in the human body.
A healthy aorta is capable of expanding and contracting with the systole and diastole heart rhythms, allowing for the flow of blood from the heart to the body. A potentially life-threatening condition affecting one's aorta is an abdominal aortic aneurysm, an abnormal expansion or ballooning of the abdominal portion of the aorta that prevents the aorta from contracting to its normal size. Aneurysms such as this may be caused by an infection, a trauma, arteriosclerosis (a hardening and narrowing of arteries), high blood pressure, genetics, or cigarette smoking. If an abdominal aortic aneurysm ruptures, the person may experience severe and often fatal blood loss.
Presently, there are two primary surgical approaches to the treatment of an abdominal aortic aneurysm: 1) open surgery and 2) endovascular surgery. An open surgery involves making an incision from the bottom of the breastbone down to the top of the pubic bone. Following the incision, muscle and/or other organs interfering with the surgeon's access to the aneurysm are shifted out of the way so that the aorta is exposed (the aorta lies at the back of the abdominal cavity, in front of the spinal column). The aorta is clamped and the aneurysm is cut open. The open section is replaced with an aortic graft, which is sewn into place using sutures so that blood may flow through the graft.
The aneurysm sac is then sewn into place around the aortic graft to prevent the fabric of the graft from rubbing against other surrounding internal organs. This procedure provides a very secure placement of the aortic graft, resulting in a reliable treatment of abdominal aortic aneurysms.
However, due to the high level of invasiveness involved, the open procedure has a number of drawbacks. Not all patients are physically capable of undergoing an open surgery. The surgery is a highly traumatic experience for the body and typically requires a long recovery period. Furthermore, individuals with an abdominal aortic aneurysm frequently suffer from other conditions, such as lung or heart problems, that render the patient incapable of handling the trauma involved in this invasive surgical option.
Another approach to treating an abdominal aortic aneurysm involves an endovascular surgery wherein the diseased section of the aorta is replaced. This procedure is commonly referred to an endovascular stent-grafting procedure. In a standard endovascular stent-grafting procedure, a surgeon makes a small incision near the groin of the patient, and maneuvers a guide wire through the vascular system to the target aneurysm, generally with the help of x-ray technology. Then, a catheter is used to deploy a stent-graft within the body at the site of the aneurysm. With the stent-graft in place, the blood flows through the stent-graft, which is bridging the aneurysm. The stent-graft holds itself in place by gripping the healthy part of the aorta above and below the diseased portion. With blood no longer flowing through the diseased part of the aorta, the aneurysm shrinks and is no longer at risk for bursting.
Although the endovascular stent-grafting procedure is a non-invasive or minimally invasive alternative to open surgery, the procedure as currently performed lacks the reliability afforded by the open surgery. Specifically, in a conventional endovascular procedure, the stent-graft is not secured or stitched in place, but rather, the stent-graft has a radial pressure that is sufficient to hold itself in place against the aortic wall. The lack of fixation of the stent-graft creates the potential for leakage of blood around the stent-graft. A leak may occur both at a seal between the stent-graft and the wall of the aorta. This type of leak, if persistent, may require further stenting or open surgery to correct. Further, a leak may cause a backflow of blood into the aortic cavity.
Furthermore, the lack of secure fixation of the stent-graft leads to slippage or migration of the stent-graft. Generally, if migration is expected, a surgeon doctor may add extensions on the distal end of the stent-graft that extend into the bifurcation of the aorta in order to hold the stent-graft in place from the bottom. However, the added security provided by these extensions are generally ineffective and do not completely prevent migration.
These problems and others persist in the variety of medical procedures identified above. Accordingly, there is a need for a device and a method for delivering and placing a plurality of securing elements in the body for the effective implementation of laparoscopic and interventional procedures.